QMS Quality Management System

The BEL Quality Management System

All BEL products and services are developed under BEL’s Quality Management System. This is a regulated environment for the company, in which all steps of product design, development, manufacture, and support are conducted with careful hazard analysis, testing, and documentation. The Quality Management System (QMS) is required for developing medical devices, to support US FDA, Chinese FDA, European CE, and other regulation. By developing all of our products under the QMS, we can assure customers that our hardware and software are both safe and effective.

The Quality Standards that guide BEL's product development

IEC 60601
Standards for safety and essential performance of medical electrical equipment
ISO 13485
QMS compliance to the standard for organizations involved in the Medical Device industry
ISO 14971
medical device risk management purposes
IEC 62304
medical device software – software life cycle processes
ISO 10993
1 Biocompatibility testing